CN103687636A - Medicament delivery device and method of controlling the device - Google Patents

Medicament delivery device and method of controlling the device Download PDF

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Publication number
CN103687636A
CN103687636A CN201280036341.3A CN201280036341A CN103687636A CN 103687636 A CN103687636 A CN 103687636A CN 201280036341 A CN201280036341 A CN 201280036341A CN 103687636 A CN103687636 A CN 103687636A
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CN
China
Prior art keywords
medicament
mode
cartridge case
controller
medicament delivery
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Granted
Application number
CN201280036341.3A
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Chinese (zh)
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CN103687636B (en
Inventor
I.埃格特
C.N.兰利
S.A.戴
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Sanofi Aventis Deutschland GmbH
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Sanofi Aventis Deutschland GmbH
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31546—Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14566—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir for receiving a piston rod of the pump
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804—Flow controllers
    • A61M5/16827—Flow controllers controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3146—Priming, e.g. purging, reducing backlash or clearance
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M2005/1787—Syringes for sequential delivery of fluids, e.g. first medicament and then flushing liquid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2403—Ampoule inserted into the ampoule holder
    • A61M2005/2407—Ampoule inserted into the ampoule holder from the rear
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2466—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase
    • A61M2005/2474—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase with movable piercing means, e.g. ampoule remains fixed or steady
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2485—Ampoule holder connected to rest of syringe
    • A61M2005/2496—Ampoule holder connected to rest of syringe via pivot
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3118—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3128—Incorporating one-way valves, e.g. pressure-relief or non-return valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/344—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub using additional parts, e.g. clamping rings or collets
    • A61M5/345—Adaptors positioned between needle hub and syringe nozzle

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • General Business, Economics & Management (AREA)
  • Primary Health Care (AREA)
  • Medical Informatics (AREA)
  • Epidemiology (AREA)
  • Business, Economics & Management (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

A medicament delivery device is shown for the administration of one or more drug agents. The device has a priming mode and a drug delivery mode for administering delivery of the one or more drug agents. The device comprises a controller configured to set the device in a priming mode when one or more predetermined states of the device are identified and to disable the drug delivery mode during said predetermined state(s). When states of the device are different from said predetermined states, the controller can set the device in the drug delivery mode. A priming mode may still be enabled through a user interface.

Description

Medicament delivery device and control the method for this device
Technical field
The present invention relates to a kind of medicament delivery device and control the method for this device, for use one or more pharmaceutical preparation to patient, particularly but not exclusively, for self-administration of pharmaceutical preparations.
Background technology
Certain morbid state requires to adopt one or more different medicines to treat.Some drugs compound need to be with specific relation conveying each other, to carry best therapeutic dose.Although present patent application is applicable to single medicament device, it is useful especially, and wherein combined therapy is desirable, but is impossible in single formula, and reason is such as but not limited to performance and the drug toxicity of stability, compromise treatment.
For example, in some cases, adopt protamine zine insulin (also can be described as first or major pharmaceutical)) and glucagon-like-peptide-1 such as GLP-1 or GLP-1 analog (also can be described as the second medicament or inferior medicament), to treat together diabetes may be favourable.
Summary of the invention
Therefore, need to be provided for carrying the device of one or more of medicaments in single injection or supplying step, this device is easy to carry out and without the complicated physical manipulation of this delivery device for user.The in the situation that of combined therapy device, the delivery device proposing provides storage holder or cartridge case holder separately to two or more active agent formulation.Then these active agent formulation are only combined and/or are transported to patient in single course of conveying.These active ingredients can be used together in the dosage of combination, or alternately, these active ingredients can combine one by one in sequential mode.
Described delivery device also allows to change the chance of the quantity of medicament.For example, a kind of Fluid Volume can for example, change by changing the characteristic (, set the changeable dosage of user or change " fixing " dosage of this device) of this injection device.The second pharmaceutical quantities can change containing packing by manufacturing various pharmaceutical pack, the second active ingredient that wherein each different packing comprises different capabilities and/or concentration.
Described delivery device can have single dispensing interface.This interface can be configured for being communicated with main reservoir and time reservoir fluid of reservoir in single medicament device situation or the medicament that comprises at least one pharmaceutical preparation in combined therapy device situation.Described medicine dispensing interface can be a class outlet that allows two or more medicaments to leave described system and be delivered to patient.
In the situation that described device is applicable to combined therapy, as separative element or as the combination of the compound of mixed cell, can be delivered to health via bullhead needle assembly.From user's visual angle, this will provide a kind of composition of medicine injecting systems, and it is to realize drug conveying with the mode of the current obtainable injection device close match with standard pin assembly.A kind of possible course of conveying can relate to following steps:
1. dispensing interface is connected to the far-end of dynamo-electric injection device.This dispensing interface comprises first and second proximal needle.The second reservoir that described first and second pin pierces through respectively the first reservoir that comprises main compound and comprises time compound.
By dosage dispenser such as bullhead needle assembly is connected to the far-end of described dispensing interface.In this way, the near-end of this needle assembly is communicated with main compound and time equal fluid of compound.
3. group choosing/set the desired amount from the main compound of this injection device, for example, via graphical user interface (GUI).
4. after user sets the dosage of main compound, the dosage of time compound can be determined or calculate to the control unit that microprocessor is controlled, and based on previously stored therapeutic dose scheme, preferably can determine or calculate this second dosage.Really be that then this combination medicament calculating will be injected by user.Described therapeutic dose scheme can be that user is optional.
5. alternatively,, after calculating the second dosage, described device can be placed under armed state.Under so optional armed state, this can by press and/or retentive control panel on " OK " button realize.This state can be for than the time period of predetermined time Duan Geng great before described device can be used to dosage that dispensing combines.
6. then, user inserts the far-end of described dosage dispenser (for example bullhead needle assembly) or be applied in desired injection position.Described main compound for example, is implemented by enabling injection user interface (injection button) with the dosage of the combination of time compound (and the 3rd potential medicament).
Two kinds of medicaments all can be via an entry needle or dosage dispenser and in an injecting step and be transferred.Compare the benefit that this is reducing user steps side's user oriented and provides convenience with implementing two independent injections.
In the actual use of the above-mentioned type medical treatment device, no matter they are for single or multiple drug delivery, may it is desirable to guarantee to start in some cases this device.
Known medicament delivery device has start-up performance, for before using medicament to patient from device or reservoir air-out.This start-up performance is by keeping up pin and operating driving mechanism until a certain amount of medicament is seen and being implemented at needle point by user.When needle point sees that medicament drips, user can guarantee, being injected in patient body is medicament rather than air.Yet the burden that such device is left user for is to remember when carry out start-up operation.Failing the less desirable consequence of starting drive is, due to the underdosage of medicament in patient body and likely by air Injection.Another difficulty is excessively or unnecessarily to start the risk of medicament, causes reducing the quantity of remaining dosage in reservoir.This difficulty comprise wherein a kind of obvious especially in the combined therapy device of two kinds of relatively low medicaments with respect to another kind of volume.
Therefore, the technical problem that the present invention faces is, reduce the risk of the unnecessary startup in above-mentioned medical treatment device and improve simultaneously start and dosage transport model between conveying time user-operable.
The object of the invention is to alleviate above-mentioned difficulties.Another object is that the user who simplifies medicament delivery device starts.The problem of moving to alleviate medicament loss by startup is also object of the present invention.
According to a first aspect of the invention, a kind of medicament delivery device is provided, for using one or more pharmaceutical preparation to patient, described device has start-up mode and the drug delivery mode of carrying one or more pharmaceutical agents for using to patient, wherein, described device comprises controller, and it can be used to: in described device being set in to start-up mode when one or more predetermined states of described device are determined and for forbidden drugs transport model during described one or more predetermined states; And, when the state of described device is different from described one or more predetermined state, described device is set in drug delivery mode, by user interface, keep enabling start-up mode simultaneously.In a preferred embodiment, user can select by user interface between start-up mode and drug delivery pattern.
The device of implementing first aspect present invention can provide simpler user interface by set force start pattern when being guaranteed by the state of this device, simultaneously other modes of operation of this device such as set and injected dose before provide and select the extra or optional user option of start-up performance.Thereby this device can reduce the medicament loss causing due to too much or unnecessary startup.
According to a second aspect of the invention, a kind of medicament delivery device is provided, for using one or more pharmaceutical preparation to patient, this device has start-up mode and the drug delivery pattern of carrying described one or more pharmaceutical preparatioies for using to patient, wherein, described device comprises controller, it can be used to and described device is set in start-up mode and for the predefined amount selecting to discharge from this device or the medicament in source, described predefined amount or source are variable, this depends on one of them of a plurality of modes of operation of being determined this device by described controller.
In the preferred embodiment of second aspect, at least one in described a plurality of modes of operation can be confirmed as any in following: when predetermined time section due to be delivered to patient before dosage and successive doses state while having passed through; Or the starting state before when predetermined amount of time has passed through due to starting before of this device.Dismountable dispensing interface that fluid for providing from this device to outlet is communicated with can be provided described device, and wherein, one of described a plurality of modes of operation are confirmed as dispensing interface starting state when dispensing interface is placed on this device.In this case, this device can comprise the first holder and the second holder, each drug reservoirs or cartridge case for keeping containing pharmaceutical preparation, and described controller can be used to patient's delivering medicament preparation.In an embodiment of second aspect, during any one or more in following: a) described dispensing interface starting state is determined; B) successive doses determined and predetermined time section surpass predefined value; Or c) before starting state determined and predetermined time section surpass predefined value, described controller can be used to be selected from the predefined amount of the first and second holders or the medicament in source.Alternately or in addition, when or a) successive doses state determined and predetermined time section be less than predefined value; Or b) starting state is determined and when predetermined time, section was less than predefined value before, and described controller can operate for selecting from the predefined amount of of the cartridge case appointment of drug reservoirs or first and second holder or the medicament in source.
Described first and second aspect is applicable to have the single therapy device of the single medicament being stored in single reservoir or cartridge case.Yet the in the situation that of combined therapy device, described one or more pharmaceutical preparatioies can comprise first and second medicament being stored in first and second reservoir.These medicaments can be same to each other or different to each other.This device can have for user set appropriate dose one or more pharmaceutical preparatioies dosing mechanism and for the driving mechanism to patient's automatic or manual delivering medicament preparation.This device can comprise prompting, to point out user to install described in true start by set date at described predetermined state.Start-up operation can be desired by user or patient, and confidence is from air and/or the residual medicament of dosage were eliminated before medicament is injected to patient before.It can be by advancing a bit of distance of driving mechanism so that the needle point that one or several medicaments appear at this device carry out.If user does not see that medicament drips, can select another start-up operation.
Dismountable dispensing interface that fluid for providing from this device to outlet is communicated with can be provided the device of implementing the present invention first or second aspect.Described outlet can comprise the adnexa for pin hub.This device can sensing pin hub and/or the connection from it or the disengaging of dispensing interface, so that be placed in this device when upper when described dispensing interface or pin hub, one of predetermined state comprises determining of dispensing interface starting state.In implementing the device of the present invention first or second aspect, when dispensing interface is confirmed as being connected to described device, and because described dispensing interface is connected to this device, without any the medicament of dosage, from this device during by dispensing, one of described predetermined state can be confirmed as dispensing interface starting state.In these cases; described controller can be used to force start function, to guarantee or give user confidence, namely in order to prepare to use this device; air is discharged from described pin hub and/or dispensing interface, so that the medicament of doses is injected in patient body.
When controller can be distinguished between different conditions, this device can respond to be suitable for the mode of any given mode of operation of this device by programming with suitable software program, thus the risk of the indefinite option that minimizing user may adopt.For example, as pointed above, may exist start-up performance to be regarded as compulsory situation and before setting dosage start-up performance may be provided for as option other situations of user.When this device provides option with startup or administration to user, user can carry out a plurality of start-up operations, to guarantee that medicament oozes present needle point, thereby guarantees that to user this device has been ready for injection.
The device that can hold more than one pharmaceutical preparation reservoir or cartridge case can comprise the first holder and the second holder, for keeping drug reservoirs or the cartridge case containing two kinds of medicaments that are likely same to each other or different to each other.Described drug reservoirs or cartridge case may comprise independently (single medicine compound) or premixed (the multiple medicines compounds of co-formulated) medical compounds.For thering is the dispensing interface of the device of first and second holder, can be provided with the bifurcated catheter that the fluid for providing from described first and second holder to single outlet is communicated with.Described pin hub can removably be connected to this single outlet.Start-up performance is realized to discharge a certain amount of medicament from this device by controlling driving mechanism by controller.The amount of medicament is preset by controller.This start-up performance is effective for the device with the above drug reservoirs of a drug reservoirs or cartridge case or or cartridge case.In the latter case, driving mechanism can be used to from each cartridge case and discharges a certain amount of medicament, so that the air from dosage before or medicament are discharged from device.Described controller can be used at device during in start-up mode and when device is in drug delivery pattern simultaneously and/or discharges successively pharmaceutical preparation to patient.
Control unit preferably includes control panel, have input equipment such as button etc., and output device is such as character display or voice unit (VU) etc.This input equipment can be configured to receive the input from user, and output device can be configured to show information, permission/do not allow function, prompting or guidance to user.
Once force start function is performed, this device is just set in drug delivery mode, keep enabling start-up mode, thereby user can select between start-up mode, to carry out extra startup or to continue to drug delivery mode simultaneously.Under this pattern, and in the situation that user is by selecting suitable indication to select extra startup via display and switch or button, described controller one of appointment from the drug reservoirs of the first and second holders or cartridge case starts this device, and condition started elapsed time and is less than and is set in for example predetermined value between 1 and 24 hour before this device between successive doses or certainly.This operating function is preserved from the medicament of non-designated in drug reservoirs or cartridge case, and it otherwise may optionally start dispensing by user.If when user between successive doses or certainly this device before start elapsed time and be greater than and select extra startup while being for example set in the predetermined value between 1 and 24 hour, described controller can be used to from the drug reservoirs of the first and second holders or cartridge case and starts this device.This is in order to make this device before setting dosage transport model upgrade the medicament in pin hub or dispensing interface.
The advantage that the device of enforcement second aspect present invention has is to provide the improvement of start-up performance and controls, thereby can reduce the medicament causing because of unnecessary or excessive startup, loses or waste.In having the device of more than one medicament, controller can be configured to be controlled at the amount of a kind of medicament of institute's dispensing during start-up performance or amount or the volume that source is less than another medicament.Like this, can reduce or reduce as much as possible owing to starting more expensive medicament or being included in less reservoir or the amount of cartridge case Chinese medicine institute dispensing.In other words, controller can be during start-up mode the medicament of the not too expensive or lower volume of dispensing preferentially.Controller can optionally be programmed when this device is enabled in user's selection, with dispensing from a medicament only in reservoir or cartridge case.
Described controller can comprise electronic control unit, and this electronic control unit can at least comprise evaluation unit, and it is configured to receive the signal from sensor unit.In this structure, sensor unit can be electronics or pickoff, it is configured to signal to be sent to evaluation unit, depends on the position of medicament or cartridge case holder and/or the locking condition of the device that locking provides, so that drug reservoirs or cartridge case are remained in device.Also may have sensor unit, it is configured to signal to be sent to evaluation unit, depends on the correct insertion of drug reservoirs.Also may have sensor unit, it is configured to signal to be sent to evaluation unit, depends on the fill level of drug reservoirs.Described sensor unit and evaluation unit can also be assemblies.
Character display can be configured to show whether cartridge case holder is opened and be filled with which drug reservoirs of which kind of type of medication and must be inserted in the cartridge case holder of opening.Equally, whether character display and voice unit (VU) can be configured to indicate drug reservoirs not correctly to be inserted in corresponding cartridge case holder.Output device can further be configured to indication about the information of the fill level of drug reservoirs.
According to a further aspect in the invention, provide a kind of control for using the method for the medicament delivery device of one or more pharmaceutical preparatioies, described method comprises: determine that when described device is in predetermined state; When the described predetermined state of described device is determined, described device is set in start-up mode; When described predetermined state is determined, forbid the drug delivery mode of described device; Determine that when described device is in the state different from described predetermined state; When being different from the state of described predetermined state and being determined, described device is set in drug delivery mode, keep enabling start-up mode simultaneously; And when described device is during in described different conditions, be convenient to select between start-up mode and drug delivery mode.
According to a further aspect in the invention, also provide a kind of control for using the method for the medicament delivery device of one or more pharmaceutical preparatioies, described method comprises: the mode of operation of determining this device from a plurality of predetermined modes of operation; The medicament of the predefined amount that selection will be discharged from from this device; And change described predefined amount, depend on which in a plurality of modes of operation of this device determined by controller.In thering is the device of more than one medicament cartridge case, change described amount and can comprise change source, with dispensing preferentially from the startup dosage of predetermined cartridge case.
According to a further aspect in the invention, provide a kind of computer program, comprised code, when it moves on processor, can operate and control for using the medicament delivery device of one or more pharmaceutical preparatioies, and control this device with:
-determine that when described device is in predetermined state;
-when the described predetermined state of described device is determined, described device is set in start-up mode;
-when described predetermined state is determined, forbid the drug delivery mode of described device;
-determine that when described device is in the state different from described predetermined state;
-when being different from the state of described predetermined state and being determined, described device is set in drug delivery mode, keep enabling start-up mode simultaneously; And
-when described device is during in described different conditions, be convenient to select between start-up mode and drug delivery mode.
According to a further aspect in the invention, provide a kind of computer-readable medium, its coding has instruction, when carrying out on computers, control for using the medicament delivery device of one or more pharmaceutical preparatioies, by:
-determine that when described device is in predetermined state;
-when the described predetermined state of described device is determined, described device is set in start-up mode;
-when described predetermined state is determined, forbid the drug delivery mode of described device;
-determine that when described device is in the state different from described predetermined state;
-when being different from the state of described predetermined state and being determined, described device is set in drug delivery mode, keep enabling start-up mode simultaneously; And
-when described device is during in described different conditions, be convenient to select between start-up mode and drug delivery mode.
Described medicament delivery device can be infusion device or injection device, for example, and hand-held insulin injection pen.Implementing medicament delivery device of the present invention can or use by medical worker or by patient oneself.As example, 1 type and type 2 diabetes mellitus can for example be treated by insulin injection dosage once a day or for several times by patient oneself.Described first and second holder can be configured to drug reservoirs or the cartridge case that maintenance comprises the pharmaceutical preparation differing from one another, and for example, in one, is Semilente Insulin pharmaceutical preparation, is protamine zine insulin pharmaceutical preparation in another.Preferably, the size of described first and second holder differs from one another, to guarantee that user is placed into correct pharmaceutical preparation in correct holder.In an embodiment of the present invention, described controller can be programmed by software, to carry out the operation of this device and predetermined state and the non-predetermined state of definite this device.
Accompanying drawing explanation
For the person of ordinary skill of the art, suitably with reference to accompanying drawing, read detailed description below, these of various aspects of the present invention and other advantages will become apparent, wherein:
Fig. 1 shows the perspective view of implementing single medicament cartridge case conveyer device of the present invention, has wherein taken off the end cap of this device;
Fig. 2 shows the perspective view of the conveyer device of Fig. 1, and difference is that it has two medicament cartridge cases;
Fig. 3 shows the perspective view of the cartridge case holder shown in Fig. 2, and wherein a cartridge case holder is in an open position;
Fig. 4 shows dispensing interface and the dosage dispenser on the conveyer device far-end being removably mounted on shown in Fig. 2;
Fig. 5 shows the dispensing interface shown in the Fig. 4 on the conveyer device far-end being arranged on shown in Fig. 2 and dosage dispenser;
Fig. 6 shows a configuration of the dosage dispenser on the conveyer device far-end that can be arranged on Fig. 1 or Fig. 2-5;
Fig. 7 shows the perspective view of the dispensing interface shown in Fig. 4;
Fig. 8 shows another perspective view of the dispensing interface shown in Fig. 4;
Fig. 9 shows the viewgraph of cross-section of the dispensing interface shown in Fig. 4;
Figure 10 shows and is arranged on delivery device than the viewgraph of cross-section of the dispensing interface on device as shown in Figure 2 and dosage dispenser;
Figure 11 a shows the part viewgraph of cross-section of the medical treatment device that represents cartridge case and display;
Figure 11 b shows the viewgraph of cross-section of the medical treatment device that represents cartridge case and driving mechanism;
Figure 12 shows for exchange the process of drug reservoirs at medical delivery device; And
Figure 13 illustrates the flow chart that device of the present invention is implemented in operation.
The specific embodiment
Delivery device shown in Fig. 1 comprises the main body 14 that extends to far-end 15 from near-end 16.At far-end 15, be provided with removable end cap or lid 18.The far-end 15 of main body 14 is worked to provide to be clasped or to form and is connected together with this end cap 18, once so that lid 18 slides on the far-end 15 of main body 14, this frictional fit between described cap and main body outer surface 20 prevents that described lid from by mistake coming off from main body.
Main body 14 comprises microprocessor control unit, dynamo-electric drivetrain and for keeping the single holder of drug reservoirs or cartridge case.When removing end cap or lid 18 time (as shown in Figure 1) from installing 10, dispensing interface 200 is mounted to the far-end 15 of main body 14, and dosage dispenser (for example needle assembly) is connected to this interface.Fluid between drug reservoirs in dispensing interface 201 provides needle assembly and remains on this device is communicated with.Delivery device 10 can be used for using by single needle assembly the medicament that calculates dosage.
Control panel district 60 is arranged near the near-end of main body 14.Preferably, this control panel district 60 comprises character display 80 and can be handled to set and inject by user a plurality of man-machine interface elements of unitized dose.In this configuration, this control panel district comprises the first dosage setting button 62, the second dosage setting button 64 and is marked with the 3rd button 66 of " OK " symbol.In addition, along the most proximal end of this main body, be also provided with injection button 74(invisible in the perspective view of Fig. 1).Cartridge case keeper 40 is removably connected to main body 14 and can comprises single cartridge case holder (not shown).
Embodiment shown in Fig. 2 has the element similar to Fig. 1 embodiment, and difference is that the cartridge case keeper 40 that is also removably connected to main body 14 can comprise at least two cartridge case holders 50 and 52.Each holder is configured to comprise a drug reservoirs, such as glass ampoules.Preferably, each cartridge case comprises different medicaments.
In addition, at the far-end of cartridge case keeper 40, the delivery device shown in Fig. 2 comprises the dispensing interface 200 being communicated with for the fluid between the drug reservoirs in needle assembly being provided and remaining on this device.As described in inciting somebody to action about Fig. 4, in a configuration, this dispensing interface 200 comprises the main outer body 212 of the far-end 42 that is removably connected to cartridge case housing 40.With regard to the embodiment of Fig. 1, the far-end 214 of dispensing interface 201 is provided and is preferably included pin hub 216 similarly.This pin hub 216 can be configured to make dosage dispenser such as traditional pen type needle assembly can removably be mounted to delivery device 10.
Once described device is unlocked, the character display 80 of Fig. 1 and Fig. 2 embodiment just throws light on and for user provides certain device information, preferably about being included in the information of the medicament in cartridge case keeper 40.For example,, for user provides some information about the single medicament of Fig. 1 or the major pharmaceutical of Fig. 2 (medicine A) and time medicament (medicine B).
As shown in Figure 3, first and second cartridge case holder 50,52 can be hinged cartridge case holder.These hinged holders allow user to take described cartridge case.Fig. 3 shows the perspective view of cartridge case keeper 40, and wherein the first hinged cartridge case holder 50 is in an open position.Fig. 3 shows user and how to take the first cartridge case 90, by opening the first holder 50 and taking thus the first cartridge case 90.The cartridge case keeper 40 of Fig. 1 is provided with the single holder similar with the holder 50 or 52 of Fig. 2 embodiment.
Dispensing interface 200 is attached to the far-end of cartridge case keeper 40.Fig. 4 shows the plan view of the dispensing interface 200 that is not connected to cartridge case keeper 40 far-ends.Also show the dosage dispenser that can use or needle assembly 400 and be arranged in the outside cap 420 of protectiveness together with interface 200.
In Fig. 5, the dispensing interface 200 shown in Fig. 4 is depicted as and is attached to cartridge case keeper 40.Axial connecting device between dispensing interface 200 and cartridge case keeper 40 can be any known axial connecting device to those skilled in the art, comprises snap lock, is clasped, the combination of snap ring, keyway and these connections.Being connected between dispensing interface and cartridge case keeper also can comprise additional feature (not shown), such as design features such as adapter, thromboembolism, spline, rib, groove, idea, clips, guarantee that specific hub is only attachable for the delivery device of coupling.This additional feature will prevent that non-suitable inferior cartridge case is inserted in non-matching injection device.
Fig. 5 also shows over cap 420 and the needle assembly 400 of the far-end that is attached to dispensing interface 200 on the pin hub that can be spun on interface 200.Fig. 6 shows the viewgraph of cross-section that is arranged on the bullhead needle assembly 400 on dispensing interface 200 in Fig. 5.
Needle assembly 400 shown in Fig. 6 comprises bullhead pin 406 and hub 401.This bullhead pin or sleeve pipe 406 are fixedly mounted in pin hub 401.This pin hub 401 comprises the element of disc-shape, and the element of this disc-shape has circumferential support sleeve 403 along its periphery.Along the medial wall of this hub member 401, be provided with screw thread 404.This screw thread 404 allows pin hub 401 to be screwed on dispensing interface 200, and it is provided with corresponding outside screw along distally hub in a preferred configuration.At the middle body of hub element 401, be provided with projection 402.The rightabout of this projection 402 from described hub along described shroud member protrudes.Bullhead pin 406 is installed between two parties through projections 402 and pin hub 401.This bullhead pin 406 is mounted to and makes first or distally of this bullhead pin pierce through the injection part that end 405 is formed for piercing through injection site (for example user's skin).
Similarly, it is outstanding that second or nearside of needle assembly 400 pierces through end 406 opposition sides from described disk, so that it is surrounded with one heart by sleeve 403.In a needle assembly configuration, described second or nearside pierce through end 406 and can be shorter than sleeve 403 so that this sleeve is protected the tip of rear side sleeve to a certain extent.Pin block 420 shown in Fig. 4 and Fig. 5 provides around the form fit of the outer surface 403 of hub 401.
Below with reference to Fig. 4 to 11, the preferred disposition to dispensing interface 200 is discussed.In this preferred disposition, this interface 200 comprises:
A. main outer body 210,
B. the first inside body 220,
C. the second inside body 230,
D. the first puncture needle 240,
E. the second puncture needle 250,
F. valve seal 260, and
G. barrier film 270.
Main outer body 210 comprises proximal 212 and body distal end 214.The near-end 212 of body 210 externally, connecting elements is configured to allow dispensing interface 200 to be connected to the far-end of cartridge case keeper 40.Preferably, this connecting elements is configured to allow dispensing interface 200 removably to connect cartridge case keeper 40.In a preferred interface configuration, the near-end of interface 200 is configured to the upwardly extending wall 218 with at least one recess.For example, can be as seen from Figure 8, upwardly extending wall 218 comprises at least the first recess 217 and the second recess 219.
Preferably, first and second recess 217,219 is positioned in this main outer body wall, to coordinate with near the member to outer process being positioned at the far-end of cartridge case housing 40 of delivery device 10.For example, this member 48 to outer process of this cartridge case housing can be found out in Fig. 4 and Fig. 5.The second similar haunched member is arranged on the opposition side of this cartridge case housing.Just because of this, when interface 200 endwisely slips on the far-end of cartridge case housing 40, to the member of outer process, will coordinate to form interference fit, form fit or snap lock with the first and second recesses 217,219.Alternately, as the skilled person will recognize, the bindiny mechanism that also can adopt the described dispensing interface of any other similar permission axially to connect with cartridge case housing 40.
The far-end of main outer body 210 and cartridge case keeper 40 works, with form can be on the far-end of described cartridge case housing the snap lock of axial engagement or snap-fit arrangement in axial sliding.In an alternative configuration, dispensing interface 200 can be provided with coding characteristic, to prevent the cross-reference of dispensing interface unintentionally.That is, the inside body of hub can be at the cross-reference unintentionally that is geometrically configured to prevent one or more dispensing interfaces.
The far-end that hub is arranged on the main outer body 210 of dispensing interface 200 is installed.This installation hub can be configured to be connected to releasedly needle assembly.Only as an example, this connecting device 216 can comprise and the outside screw engaging than the inside thread of the interior side-wall surface setting of the pin hub of needle assembly 400 as shown in Figure 6 along needle assembly.The releasable adapter substituting can also be arranged to such as snap lock, the snap lock discharging by screw thread, kayser, form fit or other similar connection configure.
Described dispensing interface 200 also comprises the first inside body 220.Some details of this inside body is shown in Fig. 8-11.Preferably, this first inside body 220 is attached to the inner surface 215 of the wall extension 218 of main outer body 210.More preferably, this first inside body 220 coordinates configuration to be attached to the inner surface of outer body 210 by rib and groove shape.For example, can be as seen from Figure 9, the wall extension 218 of main outer body 210 is provided with first rib 213a and second rib 213b.These ribs 213a and 213b are along inner surface 215 location of the wall 218 of outer body 210, and generation and the mating groove 224a of the first inside body 220 and form fit or the snap lock that 224b engages.In preferred configuration, these mating grooves 224a and 224b arrange along the outer surface 222 of the first inside body 220.
In addition, can from Fig. 8-10, find out, near the proximal face 226 near-end of the first inside body 220 can be configured at least have and comprise that the thorn that nearside pierces through the first nearside location of end 244 threads a needle 240.Similarly, the first inside body 220 is configured to have and comprises that the thorn that nearside pierces through the second nearside location of end 254 threads a needle 250.First and second pin 240,250 is all arranged in the proximal face 226 of the first inside body 220 rigidly.
Preferably, this dispensing interface 200 also comprises valve configuration.Such valve configuration can be configured to prevent from being included in respectively the cross-contamination of first and second medicament in first and second reservoir.Preferred valve configuration can also be configured to prevent backflow and the cross-contamination of first and second medicament.
In a preferred system, dispensing interface 200 comprises the valve configuration of valve seal 260 forms.Such valve seal 260 can be arranged in the cavity 231 being limited by the second inside body 230, to form holding chamber 280.Preferably, cavity 231 is positioned at along the upper surface of the second inside body 230.This valve seal comprises the upper surface that limits first fluid groove 264 and second fluid groove 266.For example, Fig. 9 shows the position of valve seal 260, and it is located between the first inside body 220 and the second inside body 230.During injecting step, this seal valve 260 contributes to prevent that the major pharmaceutical in the first path from moving to the inferior medicament in the second path, also prevents that the inferior medicament in the second path from moving to the major pharmaceutical in the first path simultaneously.This seal valve 260 comprises the first check-valves 262 and the second check-valves 268.Just because of this, the first check-valves 262 prevents that for example the groove in seal valve 260 and the fluid that transmits turn back in this path 264 along the first stream 264.Similarly, the second check-valves 268 prevents along the second stream 266 and the fluid that transmits turns back in this path 266.
As one man, first and second groove 264,266 is drawn close towards check-valves 262 and 268 respectively, and then output stream or holding chamber 280 are provided.The interior chamber that this holding chamber 280 is limited together with the barrier film 270 that can pierce through by far-end and first and second check-valves 262,268 of the second inside body limits.As shown in the figure, this barrier film that can pierce through 270 is positioned between the inner surface that the distal portions of the second inside body 230 and the pin hub of main outer body 210 limit.
Described holding chamber 280 ends at the outlet port of interface 200.This outlet port 290 is preferably centrally located in the pin hub of interface 200, and assists to maintain the sealing 270 that can pierce through and be in a fixed position.Therefore,, when bullhead needle assembly is connected to the pin hub (than bullhead pin as shown in Figure 6) of described interface, described output stream allows two kinds of medicaments to be communicated be connected needle assembly fluid.
Hub interface 200 also comprises the second inside body 230.Can be as seen from Figure 9, this second inside body 230 has the upper surface that limits recess, and valve seal 260 is positioned in this recess.Therefore,, when interface 200 is assembled as shown in Figure 9, the second inside body 230 will be positioned between the far-end and the first inside body 220 of outer body 210.As one man, the second inside body 230 and this main outer body remain on appropriate location by barrier film 270.The far-end of inside body 230 can also form cavity or holding chamber, and this cavity or holding chamber can be configured to be communicated with the first groove 264 and second groove 266 fluids of valve seal.
The main outer body 210 that endwisely slips on the far-end of described delivery device is connected to this reusable version device by dispensing interface 200.In this way, can between first pin 240 respectively with the major pharmaceutical of the first cartridge case and the inferior medicament of the second cartridge case and the second pin 250, produce fluid is communicated with.
The dispensing interface 200 of Figure 10 after showing on the far-end 42 of cartridge case keeper 40 that is installed to the delivery device 10 shown in Fig. 2.Bullhead pin 400 is also installed the so far far-end of interface.Cartridge case keeper 40 is depicted as has the first cartridge case that comprises the first medicament and the second cartridge case that comprises the second medicament.
When first interface 200 is arranged on the far-end of cartridge case keeper 40, the nearside of the first puncture needle 240 pierces through end 244 and pierces through the barrier film of the first cartridge case 90, and is communicated with major pharmaceutical 92 fluids of the first cartridge case 90 thus.The far-end of the first puncture needle 240 also will be communicated with the first flow passage groove 264 fluids that limited by valve seal 260.
Similarly, the nearside of the second puncture needle 250 pierces through end 254 and pierces through the barrier film of the second cartridge case 100, and is communicated with inferior medicament 102 fluids of the second cartridge case 100 thus.The far-end of this second puncture needle 250 also will be communicated with the second flow passage groove 266 fluids that limited by valve seal 260.
Figure 10 shows the preferred disposition with the joining this dispensing interface 200 of far-end 15 of the main body 14 of delivery device 10.Preferably, this dispensing interface 200 is removably attached to the cartridge case keeper 40 of delivery device 10.
As shown in figure 10, dispensing interface 200 is attached to the far-end of cartridge case housing 40.This cartridge case keeper 40 is depicted as and comprises the first cartridge case 90 that contains major pharmaceutical 92 and the second cartridge case 100 that contains time medicament 102.Once be attached to cartridge case housing 40, dispensing interface 200 provides in fact a kind of mechanism, and this mechanism is in order to provide from first and second cartridge case 90,100 fluid communication path to public holding chamber 280.This holding chamber 280 is depicted as with dosage dispenser fluid and is communicated with.Here, as shown in the figure, this dosage dispenser comprises bullhead needle assembly 400.As shown in the figure, the near-end of bullhead needle assembly is communicated with described chamber 280 fluids.
In a preferred configuration, described dispensing interface is configured so that it is only connected to described main body along an orientation, i.e. its only unidirectional cooperation.As shown in figure 10, once dispensing interface 200 is connected to cartridge case keeper 40, main pin 240 only can be used for being communicated with major pharmaceutical 92 fluids of the first cartridge case 90, and interface 200 will be prevented from being connected to keeper 40 so that at this moment winner's pin 240 can be used for being communicated with inferior medicament 102 fluids of the second cartridge case 100 again.This unidirectional bindiny mechanism can help to reduce the potential cross-contamination between two kinds of medicaments 92 and 102.
It is evident that, when medical treatment device 10 is put into use, may need or expect to carry out start-up operation.For example, if dispensing interface is changed, in first and second fluid conduit systems 264,266 of dispensing interface 200 and the sleeve pipe 406 of holding chamber 280 and pin hub 400, will there is air.Therefore, it is desirable to, by conduit, discharge medicament and carry out starting drive 10 until medicament appears at the far-end of pin hub 400; Thereby guarantee that air is from cartridge case 90,100 with will be inserted into the fluid communication channels between the end of the sleeve pipe 406 in patient body and discharge.In addition, one of in changing cartridge case 90,100 or both in the situation that, before any in holder 50,52 of dispensing interface 400 can be unlocked, being removed may be the Functional Requirement being programmed in this device.In this case, device 10 need to change cartridge case change dispensing interface 200 or new dispensing interface 200 after startup.The volume of the conduit in the dispensing interface 200 that will be filled in start-up course can be the magnitude of 1 μ l.Below with reference to Figure 13, to installing 10 startup, illustrate in greater detail.
Figure 11 a shows the viewgraph of cross-section of medical treatment device 10.Two cartridge case holders 50 and 52 are depicted as in the closed position.Holder 50 is configured to contain drug reservoirs 620, and holder 52 is configured to contain drug reservoirs 622.Reservoir 620,622 can be glass, metal or plastic cartridge casep.Reservoir 622 can have than the less diameter of reservoir 620 and shorter length.
Cartridge case keeper 40 can also comprise two locking devices 600 and 602. Locking device 600 and 602 can be designed to door bolt, and it can be locked in cartridge case holder 50,52 their closed position in the mode of form fit.
Locking device 600 and 602 can be released or release by operation cartridge case release-push 604 and 606.Cartridge case release-push 604 and 606 can mechanically or dynamo-electricly be worked.
Cartridge case keeper 40 also comprises two cartridge case holder springs 608 and 610, and its closed position in cartridge case holder 50 and 52 applies elasticity elastic force on cartridge case holder.By release locking device 600 and 602, elastic force impels cartridge case holder 50 and 52 to move at open position.
Cartridge case holder 50 is hinged to the cartridge case holder housing at gantry post 612, and cartridge case holder 52 is hinged to the cartridge case holder housing at gantry post 614.Thereby cartridge case holder 50,52 can be around gantry post 612,614 pivotable between their closed and opened position.
Cartridge case keeper 40 can also comprise cartridge detection switch 616 and 618. Cartridge detection switch 616 and 618 can be configured to detect the insertion state of corresponding medicament cartridge case 620,622 and/or the closed condition of cartridge case holder 50 and 52.
Equipment 10 also comprises controller 700, and it can be microprocessor control unit, has the software of programming therein, for carrying out the function of this device, as illustrated in greater detail below with reference to Figure 12 and 13.Controller 700 can comprise evaluation unit 702, and it can be configured to receive the signal from cartridge detection switch 616 and 618.Evaluation unit 702 can also be configured to receive from the signal of sensor that is configured to determine the fill level of cartridge case 620,622.
Preferably, controller 700 is connected to user interface, and for example control panel region 60.Preferably, described user interface or control panel region 60 comprise that output device is such as character display 80 and input equipment are such as keyboard, for example, comprise dosage setting button 62 and 64 or specify the button 66 that has symbol " OK " (being shown in the position in Fig. 1-3 embodiment different from Figure 12 embodiment).At the near-end of main body 14, further provide injection button 74.
Figure 11 b is the view similar with Figure 11 a, and difference is to show with the form of whole cross sections the schematic diagram of paired drivetrain 624 and 625.This first drivetrain 624 to drivetrain comprises by the motor 626 of gear 628 piston rod 627.Drivetrain 624 can be used to piston rod 627 under the control of controller 700, the medicament with dispensing from cartridge case 620.The second drivetrain 625 comprises motor 629, for via the second gear mechanism 631 piston rod 630, with same under the control of controller 700 dispensing from the medicament of cartridge case 622.
Figure 12 shows the process that exchanges cartridge case in medical delivery device 10.In step 800, the controller 700 of medical treatment device 10 determines that the cartridge case in holder 50 is empty, and therefore controller 700 enters " cartridge case exchange or replacing pattern ".Therefore, character display 80 shows that medicine B is empty.Equally, in step 800, it is to need that of exchange that character display 80 shows the cartridge case 620 with major diameter and big-length.
Before user is allowed to approach cartridge case holder 50, this device indicating user in step 802 is removed dispensing interface.This illustrates on character display 80.Indication on the character display 80 shown in step 800 and 802 may replace within a period of time.Subsequently, dispensing interface 200 removes in step 802 from cartridge case keeper 40.
In step 804, controller 700 determines that dispensing interface 200 removes from cartridge case keeper 40.Further, in step 804, controller 700 can be operable to released state by locking device 600 and 602, if they under the state of not release simultaneously dispensing interface 200 be connected to cartridge case keeper 40.Meanwhile, character display 80 indication operational correspondences are in the cartridge case release-push 604 of the cartridge case that will exchange.When user presses cartridge case release-push 604, controller 700 makes driving mechanism 624 from cartridge case 620 retraction piston rods 627, because piston rod 627 is retracted from cartridge case 620, so in step 806, show " please wait for " instruction on display.When piston rod 627 is retracted completely, motor 626 stalls and signal are sent to controller 700, to trigger locking device 600 to non-locking or release conditions, thereby allow cartridge case release-push 604 to open cartridge case holder 50.When motor stalling, for the encoder (not shown) of monitoring driving mechanism, by controller 700, be placed in " data reset " state.And now, locking device 602 is manipulated into non-released state, if this is not yet performed to once only can open a cartridge case holder 50,52 before.
In step 808, cartridge case holder 50 is pushed out closed position to open position by cartridge case holder spring 608.Also have likely, cartridge case holder 50 is pushed out in open position by user, and there is no the help of elasticity elastic force.Once cartridge case holder 50 has been opened, sense switch 616 just sends corresponding signal to controller 700.Character display 80 is indicated subsequently to insert and is filled with the new cartridge 622 of medicine B, and shows the cartridge case with major diameter and big-length.
Opening by controller 700 of cartridge case holder 50 detects, then the 626 sufficiently long times of operation of motor, with the certain distance of propelling piston bar 627, this locking device 600 that resets when permission is closed by user after it is changing cartridge case.The sense switch 616 being associated with holder 50 detects the existence of the cartridge case 620 in holder 50.In step 810 subsequently, cartridge case holder 50 is manually moved to closed position, and it is locked by locking device 600 at this.In closed position, sense switch 616 sends corresponding signal to controller 700.The insertion state of the cartridge case inserting can also be presented on character display 80.New cartridge 620 is being placed in after holder 50, and user closes holder 50, and sense switch 616 transmissions exist the signal of cartridge case to controller 700.When holder 50 is closed, door bolt or locking device 600 can signal to described controller.According to the step procedure corresponding to above-mentioned steps 800 to 810, above-mentioned cartridge case exchange process is applicable to other cartridge case 622 and it is replaced with cartridge case holder 52.If this cartridge case is also empty, this will be presented on display 80 as in step 800, but that represent is medicine A, rather than medicine B.
When device 10 is put into while using, controller 700 is carried out a series of status checkouts, to determine that dispensing interface is whether on this device.If do not existed, controller will point out user to connect dispensing interface.If, whether controller will determine because dispensing interface is connected the medicament of dispensing doses.Which kind of mode no matter, controller 700 force starts operations, will illustrate in greater detail below.
At first, this device may be in the indicated state of Figure 12 step 804, for example, in its corresponding holder 50,52 without any medicine A or medicine B cartridge case.User inserts drug cartridge in above-mentioned mode, so that when the two is loaded, display represents this situation by demonstration " cartridge case is written into " in step 810.After in cartridge case 620,622 one or both of is written into this device, controller 700 can " connect dispensing interface " by display reminding, so user can be connected to cartridge case keeper 40 by dispensing interface 200, can move thus force start operation as described below.
When this device comprises medicament cartridge case, controller 700 is for example by the connection (or not connecting) of the dispensing interface 200 at least one switch or sensor sensing cartridge case keeper 40.If dispensing interface do not detected, controller 700 promptings are connected to cartridge case keeper 40 by dispensing interface 200.After connecting dispensing interface, controller 700 is set device 10 for force start pattern.This start-up mode will be for being present in the Bas Discharged of the dispensing interface 200 that has been connected to cartridge case keeper 40.If controller 700 senses, have dispensing interface, need force start operation, prerequisite is if do not have dosage to be performed because dispensing interface is connected via this device.This probability providing is, user connects dispensing interface and then do not take further action until the time after a while.When the time is after a while on this device during switch, force start dosage will be essential.Yet, if on device activates, controller 700 sensings be dosage because dispensing interface is connected, carried or force start step because dispensing interface is connected and has carried out, may not need force start, in this case, administration functions is activated, and user can select to start or administration.
Therefore, controller 700 can comprise software, can be used to following state or the operating conditions of determining device 10:
A. detecting dispensing interface 200 is connected with cartridge case keeper 40;
B. dispensing interface starting state;
C. drug delivery mode state;
D. the time period Td from the last administration of medicament is greater than or less than the first predefined value Tds; And
E. the time period Tp from last start-up operation is greater than or less than the second predefined value Tps.
Figure 13 is flow chart, and with reference to this figure, the operating sequence of implementing device of the present invention is as described below.Device 10 is switched on or starts in step 900, and controller 700 is set up dispensing interface 200 and whether is connected to cartridge case keeper 40 in step 905 subsequently.If no, controller 700 makes display 80 show the suitable user that is prompted to, such as " connecting dispensing interface ".When dispensing interface 200 connects, controller is determined the state that dispensing interface 200 is connected with cartridge case keeper 40 in step 910.If what determine in step 910 is that dispensing interface 200 has been connected, controller 700 is set device 10 for " dispensing interface starting state ", i.e. force start in step 920, and this forms this and installs in numerous predetermined states.In this state, device 10 drug delivery mode state is by controller 700 and disabled, thereby the force start of this device can be carried out by this device.This state can be presented on display 80 by the software of controller 700, makes administration option unavailable.Therefore, dosage setting button 62,64 is disabled under this state.Display 80 can represent startup command or prompting.This software identification is pressed " OK " button 66 and carries out start-up operation.Start-up operation is controlled by the software being programmed in controller 700.Step 925 judges that force start operation completes.If no, occur pointing out and starting this device to user.If this operation is successfully completed, administration functions is enabled in step 930, in step 945, to user, selects administration or startup.
If in step 905, dispensing interface has been connected to this device, and controller need determine whether to need force start operation, or it's not true and user can select to start.So if step 905 is answered "Yes",, in step 915, controller 700 determines whether because dispensing interface 200 is connected to this device and has the drug dose that this device is carried.If there is no (being that step 915 is answered "No"), force start operation is essential, and controller proceeds to step 920 as above.On the other hand, if answer is "yes" in step 915, administration functions is enabled in step 930, and user is presented selection startup or administration in step 945.
In the situation that there is the device of two medicament cartridge cases, during carrying out start-up operation from the conveying of the medicament of cartridge case can be simultaneously or continuous.Software control driving mechanism 624,625, to eject from the predefined amount of corresponding cartridge case 620,622 or the medicament of dosage.In the situation that the size/capacity of cartridge case is different, the amount of carrying from a cartridge case or dosage may be different or change relative to each other.Preferably, starting dosage is preset and is paired in the far-end that is enough to appear at pin hub 400 medicament.In step 925, judge completing of force start operation, in step 930, enable subsequently the drug delivery mode state of device 10.
In step 945, the user that the software in controller 700 receives optional start-up performance or administration conveying function selects.If what carry out in step 945 is administering selected, controller 700 carries out dosage setting program in step 946, and this is convenient to set drug dose.In step 947, the dosage of setting is carried when activating injection button 74.
If what select in step 945 is optional start-up operation, the software in controller 700 selects to depend on the medicament by the predefined amount that will discharge from this device of controller 700 determined modes of operation.The in the situation that of single drug reservoirs device, the medicament of the predefined amount that will discharge during optional start-up mode can be chosen to by controller software different, and this depends on definite state of this device.For example, predefined amount be certainly delivered to patient before administration through predetermined time, can be a value during section, if or controller determine that before this device, starting through predetermined time may be different values during section.If what determine is that medicament cartridge case is replaced, can set another value.
At two cartridge cases or drug reservoirs device such as shown in Fig. 2-11b in the situation that, the predefined amount of change during optional start-up mode can realize by ejecting from the medicament of one or two reservoir, depends on one of unit state by the determined numerous pre-programmed of controller 700 software.Controller 700 softwares are determined: a) in step 950, whether oneself has passed through from the last administration of the medicament of this device the time period Td that is greater than or less than the first preset value Tds; And b), in step 955, from the time period Tp of last start-up operation, whether be greater than or less than the second preset value Tps.Td is greater than Tds or Tp is greater than in the situation of Tps therein, and so optional startup carried out by controller 700, the medicament with dispensing from the predefined amount of two cartridge cases (step 960), thus effectively " wash and dress " dispensing interface 200.
Controller 700 softwares determine that Td is less than Tds and Tp is less than in the situation of Tps therein, and controller 700 softwares optionally start (step 965) from one of described medicament cartridge case only.Between this optional starting period, medicament is from the cartridge case of wherein discharging that of smaller size smaller preferably, to preserve the medicament being included in wherein.Any in Tds and Tps or both values can be set as for example 24 hours, although different Tds or Tps section can be set as any time or another section between 1 and 24 hour, are considered as being suitable for being intended to the medical applications for installing in formation or during arranging.
Be noted that optional start-up routine in step 945 at one's discretion user process and repeatedly carry out continuously.Therefore, optional start-up operation may increase, until user is satisfied with or be sure of to have filled enough medicaments at the device for injecting, this perhaps determines by the some drops at needle point.
In the situation that thereby residual medicament deficiency affects start-up performance in cartridge case, controller will be carried out in the program shown in Figure 13, to point out user to change empty cartridge case so.This will impel and remove dispensing interface (see Figure 12 802), and this is conversely by the force start function causing when reconnecting dispensing interface.
Figure 12 and/or 13 operating sequence can be by being stored in computer-readable medium such as the computer program on CD-ROM970 or memory stick 975 is carried out.
The term that used in this article " medicine " or " medicament " mean the pharmaceutical formulation that contains at least one pharmaceutically active compound,
Wherein, in one embodiment, described pharmaceutically active compound has and reaches the molecular weight of 1500Da and/or be peptide, protein, polysaccharide, vaccine, DNA, RNA, enzyme, antibody or its fragment, hormone or oligonucleotide, or the mixture of above-mentioned pharmaceutically active compound
Wherein, in another embodiment, described pharmaceutically active compound can be used for treating and/or preventing diabetes or the complication relevant to diabetes such as diabetic renal papillary necrosis, thromboembolism disease are such as dark vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, degeneration of macula, inflammation, pollinosis, atherosclerosis and/or rheumatoid arthritis
Wherein, in another embodiment, described pharmaceutically active compound comprise at least one be used for the treatment of and/or prevent diabetes or the complication relevant to diabetes such as the peptide of diabetic renal papillary necrosis,
Wherein, in another embodiment, described pharmaceutically active compound comprises at least one insulin human or human insulin analogue or derivant, glucagon-like peptide (GLP-1) or its analog or derivant, or exedin-3 or exedin-4, or the analog of exedin-3 or exedin-4 or derivant.
Insulin analog is for example Gly(A21), Arg(B31), Arg(B32) insulin human; Lys(B3), Glu(B29) insulin human; Lys(B28), Pro(B29) insulin human; Asp(B28) insulin human; Insulin human, wherein the proline of B28 position is substituted by Asp, Lys, Leu, Val or Ala, and wherein the Lys of B29 position can be substituted by Pro; Ala(B26) insulin human; Des(B28-B30) insulin human; Des(B27) insulin human and Des(B30) insulin human.
Insulin derivates is for example B29-N-myristoyl-des(B30) insulin human; B29-N-palmityl-des(B30) insulin human; B29-N-myristoyl insulin human; B29-N-palmityl insulin human; B28-N-myristoyl Lispro; B28-N-palmityl-Lispro; B30-N-myristoyl-ThrB29LysB30 insulin human; B30-N-palmityl-ThrB29LysB30 insulin human; B29-N-(N-palmityl-Y-glutamy)-des(B30) insulin human; B29-N-(N-stone gallbladder acyl-Y-glutamy)-des(B30) insulin human; B29-N-(ω-carboxyl heptadecanoyl)-des(B30) insulin human and B29-N-(ω-carboxyl heptadecanoyl) insulin human.
Exendin-4 for example means Exendin-4(1-39), a kind of sequence is H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Me t-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-As n-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH 2peptide.
Exendin-4 derivant is for example selected from following compounds:
H-（Lys）4-des?Pro36,des?Pro37Exendin-4（1-39）-NH2，
H-（Lys）5-des?Pro36,des?Pro37Exendin-4（1-39）-NH2，
des?Pro36[Asp28]Exendin-4（1-39），
des?Pro36[IsoAsp28]Exendin-4（1-39），
des?Pro36[Met（O）14,Asp28]Exendin-4（1-39），
des?Pro36[Met（O）14,IsoAsp28]Exendin-4（1-39），
des?Pro36[Trp（O2）25,Asp28]Exendin-4（1-39），
des?Pro36[Trp（O2）25,IsoAsp28]Exendin-4（1-39），
des?Pro36[Met（O）14Trp（O2）25,Asp28]Exendin-4（1-39），
Des Pro36[Met(O) 14Trp(O2) 25, IsoAsp28] Exendin-4(1-39); Or
des?Pro36[Asp28]Exendin-4（1-39），
des?Pro36[IsoAsp28]Exendin-4（1-39），
des?Pro36[Met（O）14,Asp28]Exendin-4（1-39），
des?Pro36[Met（O）14,IsoAsp28]Exendin-4（1-39），
des?Pro36[Trp（O2）25,Asp28]Exendin-4（1-39），
des?Pro36[Trp（O2）25,IsoAsp28]Exendin-4（1-39），
des?Pro36[Met（O）14Trp（O2）25,Asp28]Exendin-4（1-39），
des?Pro36[Met（O）14Trp（O2）25,IsoAsp28]Exendin-4（1-39），
Wherein, described group-Lys6-NH2 can be bonded to the C-end of Exendin-4 derivant;
Or there is the Exendin-4 derivant of following sequence
H-（Lys）6-des?Pro36[Asp28]Exendin-4（1-39）-Lys6-NH2，
des?Asp28Pro36,Pro37,Pro38Exendin-4（1-39）-NH2，
H-（Lys）6-des?Pro36,Pro38[Asp28]Exendin-4（1-39）-NH2，
H-Asn-（Glu）5des?Pro36,Pro37,Pro38[Asp28]Exendin-4（1-39）-NH2，
des?Pro36,Pro37,Pro38[Asp28]Exendin-4（1-39）-（Lys）6-NH2，
H-（Lys）6-des?Pro36,Pro37,Pro38[Asp28]Exendin-4（1-39）-（Lys）6-NH2，
H-Asn-（Glu）5-des?Pro36,Pro37,Pro38[Asp28]Exendin-4（1-39）-（Lys）6-NH2，
H-（Lys）6-des?Pro36[Trp（O2）25,Asp28]Exendin-4（1-39）-Lys6-NH2，
H-des?Asp28Pro36,Pro37,Pro38[Trp（O2）25]Exendin-4（1-39）-NH2，
H-（Lys）6-des?Pro36,Pro37,Pro38[Trp（O2）25,Asp28]Exendin-4（1-39）-NH2，
H-Asn-（Glu）5-des?Pro36,Pro37,Pro38[Trp（O2）25,Asp28]Exendin-4（1-39）-NH2，
des?Pro36,Pro37,Pro38[Trp（O2）25,Asp28]Exendin-4（1-39）-（Lys）6-NH2，
H-（Lys）6-des?Pro36,Pro37,Pro38[Trp（O2）25,Asp28]Exendin-4（1-39）-（Lys）6-NH2，
H-Asn-（Glu）5-des?Pro36,Pro37,Pro38[Trp（O2）25,Asp28]Exendin-4（1-39）-（Lys）6-NH2，
H-（Lys）6-des?Pro36[Met（O）14,Asp28]Exendin-4（1-39）-Lys6-NH2，
des?Met（O）14Asp28Pro36,Pro37,Pro38Exendin-4（1-39）-NH2，
H-（Lys）6-desPro36,Pro37,Pro38[Met（O）14,Asp28]Exendin-4（1-39）-NH2，
H-Asn-（Glu）5-des?Pro36,Pro37,Pro38[Met（O）14,Asp28]Exendin-4（1-39）-NH2，
des?Pro36,Pro37,Pro38[Met（O）14,Asp28]Exendin-4（1-39）-（Lys）6-NH2，
H-（Lys）6-des?Pro36,Pro37,Pro38[Met（O）14,Asp28]Exendin-4（1-39）-（Lys）6-NH2，
H-Asn-（Glu）5des?Pro36,Pro37,Pro38[Met（O）14,Asp28]Exendin-4（1-39）-（Lys）6-NH2，
H-Lys6-des?Pro36[Met（O）14,Trp（O2）25,Asp28]Exendin-4（1-39）-Lys6-NH2，
H-des?Asp28Pro36,Pro37,Pro38[Met（O）14,Trp（O2）25]Exendin-4（1-39）-NH2，
H-（Lys）6-des?Pro36,Pro37,Pro38[Met（O）14,Asp28]Exendin-4（1-39）-NH2，
H-Asn-（Glu）5-des?Pro36,Pro37,Pro38[Met（O）14,Trp（O2）25,Asp28]Exendin-4（1-39）-NH2，
des?Pro36,Pro37,Pro38[Met（O）14,Trp（O2）25,Asp28]Exendin-4（1-39）-（Lys）6-NH2，
H-（Lys）6-des?Pro36,Pro37,Pro38[Met（O）14,Trp（O2）25,Asp28]Exendin-4（S1-39）-（Lys）6-NH2，
H-Asn-（Glu）5-des?Pro36,Pro37,Pro38[Met（O）14,Trp（O2）25,Asp28]Exendin-4（1-39）-（Lys）6-NH2；
Or any pharmaceutically acceptable salt or solvate in aforementioned Exedin-4 derivant.
Hormone is for example hypophysis hormones or thalamus hormones or modulability bioactive peptide and their antagonist, as listed in Rote Liste2008 version the 50th chapter, such as promoting sexual gland hormone (Gonadotropine) (follicle stimulating hormone (Follitropin), lutropin (Lutropin), chorionic-gonadotropin hormone (Choriongonadotropin), thylakentrin (Menotropin)), growth hormone (Somatropine) (growth hormone (Somatropin)), Desmopressin (Desmopressin), terlipressin (Terlipressin), gonadorelin (Gonadorelin), triptorelin (Triptorelin), leuprorelin (Leuprorelin), buserelin (Buserelin), nafarelin (Nafarelin), goserelin (Goserelin).
Polysaccharide is for example glucosaminoglycan, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or their derivant, or hydrosulphate, the poly sulphation form of above-mentioned polysaccharide for example, and/or pharmaceutically acceptable salt wherein.The example of the pharmaceutically acceptable salt of poly sulphation low molecular weight heparin is Enoxaparin Sodium (enoxaparin sodium).
Antibody is spherical plasma protein (～150kDa), is also referred to as the immunoglobulin of sharing basic structure.Because they have the sugar chain that is added into amino acid residue, so they are glycoproteins.The basic functional units of each antibody is immunoglobulin (Ig) monomer (only comprising an Ig unit); The antibody of secretion can be also have two Ig unit such as the dimer of IgA, there are four Ig unit such as the tetramer of bony fish IgM or there are five Ig unit such as the pentamer of mammal IgM.
Ig monomer is " Y " shape molecule that comprises 4 polypeptide chains; Article two, identical heavy chain and two identical light chains are connected by the disulfide bond between cysteine residues.Every heavy chain is approximately 440 amino acid longs; Every light chain is approximately 220 amino acid longs.Heavy chain and light chain comprise respectively makes their folding stable intrachain disulfide bonds.Each chain consists of the domain in so-called Ig territory.These territories comprise an about 70-110 aminoacid, and are divided into different classification (for example, variable or V, and constant or C) according to their size and function.They have distinctive immunoglobulin folding, and wherein two β sheets create " sandwich " shape, and its cysteine by preservation and the interaction between the aminoacid of other electric charges keep together.
There is the mammal Ig heavy chain of five types, by α, δ, ε, γ and μ, represented.The type definition of the heavy chain existing the antibody of isotype; These chains are found respectively in IgA, IgD, IgE, IgG and IgM antibody.
The size of different heavy chains is different from composition; α and γ comprise approximately 450 aminoacid, and δ comprises approximately 500 aminoacid, and μ and ε have approximately 550 aminoacid.Each heavy chain has Liang Ge district, constant region (CH) and variable region (VH).In species, constant region is identical substantially in all antibody of same isotype, but is different in the antibody of different isotypes.Heavy chain γ, α and δ have constant region that the Ig territory by three series connection forms and in order to increase the hinge region of motility; Heavy chain μ and ε have the constant region consisting of four immunoglobulin domains.The variable region of heavy chain is different in the antibody being produced by different B cell, but is identical for all antibody that produced by single B cell or B cell clone.The variable region of each heavy chain is approximately 110 amino acid longs, and consists of single Ig territory.
In mammal, there is the light chain immunoglobulin of two types, by λ and κ, represented.Light chain has two continuous territories: a constant domain (CL) and a variable domain (VL).The length of light chain is about 211 to 217 aminoacid.Each antibody comprises two always identical light chains; Only have light chain κ or the λ of one type to be present in mammiferous each antibody.
Although the general structure of all antibody is closely similar, the particular feature of given antibody is definite by variable region (V), as mentioned above.More particularly, variable loop, upper three of light chain (VL) upper three and heavy chain (VH), be responsible for antigen combination, i.e. its antigenic specificity.These rings are called as complementarity-determining region (CDR).Because the CDR from VH and VL territory contributes to antigen binding site, so be not any independent chain but the combination of heavy chain and light chain determines final antigenic specificity.
" antibody fragment " comprises at least one Fab as defined above, and has substantially the same function and the specificity of complete antibody being derived from fragment.The limited proteolytic digestion with papain is divided into three fragments by Ig prototype.Two identical amino terminal fragments are Fab (Fab), and each comprises a complete L chain and about half H chain.The 3rd fragment is FC (Fc), but similar half comprising with the carboxyl terminal of two heavy chains of they interchain disulfide bonds of its size.Fc comprises carbohydrate, complement combination and FcR binding site.Limited pepsin digestion produces the single F(ab' that comprises Fab sheet and hinge region) 2 fragments, comprise H-H interchain disulfide bond.F(ab') the 2nd, the antigen combination of bivalence.F(ab') 2 disulfide bond can be cut to obtain Fab'.In addition, the variable region of heavy chain and light chain can fuse together, to form single chain variable fragment (scFv).
Pharmaceutically acceptable salt is for example acid-addition salts and basic salt.Acid-addition salts is for example the salt of HCl or HBr.Basic salt is for example to have the cationic salt that is selected from alkali or alkaline matter, described cation is for example Na+ or K+ or Ca2+, or ammonium ion N+(R1) (R2) (R3) (R4), wherein, R1 to R4 means independently of one another: hydrogen, the C1-C6-alkyl optionally replacing, the C2-C6-thiazolinyl optionally replacing, the C6-C10-aryl optionally replacing or the C6-C10-heteroaryl optionally replacing.Other example of pharmaceutically acceptable salt has been described in the 17th edition < < Lei Mingdun formulation science (Remington's Pharmaceutical Sciences) the > > being edited by Alfonso R.Gennaro publishing at the Mark Publishing Company of Pennsylvania, America Easton in 1985 and < < preparation technique encyclopedia (Encyclopedia of Pharmaceutical Technology) > >.
Pharmaceutically acceptable solvate is for example hydrate.

Claims (17)

1. a medicament delivery device, be used for using one or more pharmaceutical preparatioies, described device has drug delivery mode and the start-up mode of carrying one or more pharmaceutical agents for using, wherein, described device comprises controller, and it can be used to: in described device being set in to start-up mode when one or more predetermined states of described device are determined and for forbidden drugs transport model during described one or more predetermined states; And, when the state of described device is different from described one or more predetermined state, described device is set in drug delivery mode, by user interface, keep enabling start-up mode simultaneously.
2. medicament delivery device according to claim 1, wherein, when dispensing interface is placed in described device from separation relation to annexation, one of described predetermined state is confirmed as dispensing interface starting state.
3. medicament delivery device according to claim 1, wherein, when dispensing interface is confirmed as being connected to described device, and because described dispensing interface is connected to described device, without any the medicament of dosage, from described device during by dispensing, one of described predetermined state is confirmed as dispensing interface starting state.
4. according to claim 1, claim 2 or medicament delivery device claimed in claim 3, wherein, described medicament delivery device comprises the first holder and the second holder, each medicament cartridge case for keeping containing pharmaceutical preparation.
5. medicament delivery device according to claim 4, comprises and having for dismountable dispensing interface of the bifurcated catheter of the fluid connection from described the first and second holders to single outlet is provided.
6. medicament delivery device according to claim 5, wherein, described single outlet comprises the adnexa for pin.
7. according to the medicament delivery device described in any one in claim 4 to 6, wherein, when described predetermined state is confirmed as dispensing interface starting state, described controller can be used to difference dispensing from the fluid of the medicament cartridge case of described first and second holder.
8. according to the medicament delivery device described in any one in claim 1 to 7, wherein, described device comprises prompting, to point out user to install described in true start by set date at described predetermined state.
9. according to the medicament delivery device described in any one in claim 1 to 8, wherein, when described device is set in drug delivery mode while keeping enabling start-up mode simultaneously, if from before dosage or started elapsed time and be less than predetermined value before described device, described controller can be used to of from the medicament cartridge case of described the first and second holders appointment and starts described device.
10. according to medicament delivery device in any one of the preceding claims wherein, wherein, when described device is set in drug delivery mode while keeping enabling start-up mode simultaneously, if from before dosage or started elapsed time and be greater than predetermined value before described device, described controller can be used to from two medicament cartridge cases of described the first and second holders and starts described device.
11. according to the medicament delivery device described in any one in claim 1 to 10, wherein, described controller can be used in enabling the process of start-up mode and with different speed, from the drug reservoirs of described the first and second holders, discharges medicament relative to each other.
12. according to medicament delivery device in any one of the preceding claims wherein, and wherein, described start-up mode from discharging a certain amount of medicament in the predefined device of described controller institute.
13. medicament delivery devices according to claim 12, wherein, under start-up mode, described controller can be used to many discrete units and discharges a certain amount of medicament, and the quantity of described discrete unit is selected by user interface.
14. according to the medicament delivery device described in claim 12 or claim 13, and wherein, the predetermined amount of medicament depends on determined predetermined state.
15. according to medicament delivery device in any one of the preceding claims wherein, and wherein, dose setting device is enabled during drug delivery mode.
16. according to medicament delivery device in any one of the preceding claims wherein, and wherein, described device is hand-held and/or pen type injection device.
17. 1 kinds of controls are for using the method for the medicament delivery device of one or more pharmaceutical preparatioies, and described method comprises:
-determine that when described device is in predetermined state;
-when the described predetermined state of described device is determined, described device is set in start-up mode;
-when described predetermined state is determined, forbid the drug delivery mode of described device;
-determine that when described device is in the state different from described predetermined state;
-when being different from the state of described predetermined state and being determined, described device is set in drug delivery mode, keep enabling start-up mode simultaneously; And
-when described device is during in described different conditions, be convenient to select between start-up mode and drug delivery mode.
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US20170143908A1 (en) 2017-05-25
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US10213557B2 (en) 2019-02-26
US9572932B2 (en) 2017-02-21

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